510(k) K040611 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
MODULAR RADIAL HEAD REPLACEMENT DEVICE
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 4, 2004 |
| Received | Mar 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2014 | Biomet, Inc. ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant. Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.